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Systematic review and meta-analysis

This trial is included in the following systematic reviews and meta-analyses:

atrial fibrillation - antithrombotics - primary prevention of thromboembolic events

atrial fibrillation - new oral anticoagulants - all type of patients


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Lip (phase 2 AZD0837), 2009 - AZD0837 vs warfarin standard dose

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See also:

  • All atrial fibrillation clinical trials
  • All clinical trials of new oral anticoagulants
  • All clinical trials of AZD0837
  •  
     Lip (phase 2 AZD0837) study, 2009 TRC11459 
    [NCT00684307] unpublished (or not yet fully published) trial Preliminary results download pdf: AZD0837 | antithrombotics for atrial fibrillation

    Treatments

    Studied treatment AZD0837 for 3-9 months
    Control treatment dose-adjusted Vitamin-K antagonists (VKA) (aiming for an international normalized ratio (INR) 2.0 to 3.0)
    Remarks 4 doses: 150 mg od, 300mg od, 450 mg od and 200mg bid

    Patients

    Patients patients with non-valvular atrial fibrillation (AF) with one or more additional risk factors for stroke
    Inclusion criteria 1) Nonvalvular AF (NVAF) verified by at least two ECGs in the last year separated by at least one week.; 2) Previous cerebral ischemic attack (stroke or TIA, >30 days prior to randomization); 3) Previous systemic embolism.; 4) Symptomatic congestive heart failure (CHF); 5) Impaired left ventricular systolic function; 6) Diabetes mellitus; 7) Hypertension requiring anti-hypertensive treatment.;
    Exclusion criteria 1) AF secondary to reversible disorders, eg hyperthyroidism, drugs and pulmonary embolism; 2) Known contraindication to VKA treatment; 3) Presence of a valvular heart disease, mechanical heart valves, active endocarditis, left ventricular aneurysm or thrombus, atrial myxoma or any condition other than AF requiring chronic anticoagulation treatment; 4) Conditions associated with increased risk of major bleeding for example: history of intracranial bleeding, history of bleeding gastrointestinal disorder or major surgical procedure or trauma two weeks prior to randomization;
    Baseline characteristics
    subgroup test

    Method and design

    Randomized effectives 636 / 318 (studied vs. control)
    Design Parallel groups
    Blinding double blind
    Follow-up duration 3 or 9 months
    Primary endpoint Safety variables
    Studied endpoints Safety variables, Pharmacokinetic parameters, Pharmacodynamic markers, Pharmacogenetics,

    Remarks / Comments

    phase 2



    Results

    No results available for this trial - unpublished or not fully published trial

    Meta-analysis of all similar trials:

    antithrombotics in atrial fibrillation for primary prevention of thromboembolic events

    new oral anticoagulants in atrial fibrillation for all type of patients



    Reference(s)

    TrialResults-center ID TRC11459
    Trials register # NCT00684307

    unpublished (or not yet fully published) trial

    • Lip GY, Rasmussen LH, Olsson SB, Jensen EC, Persson AL, Eriksson U, Wåhlander KF. Oral direct thrombin inhibitor AZD0837 for the prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation: a randomized dose-guiding, safety, and tolerability study of four doses of AZD0837 vs. vitamin K antagonists.. Eur Heart J 2009;30:2897-907 - 10.1093/eurheartj/ehp318
      Pubmed | Hubmed | Fulltext

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